Haloperidol, also known as 4-[4-(-chlorophenyl)-4-hydroxy-1-piperidnyl]-1-(4-fluorophenyl)-1-butanone , is a tranquilizer drug indicated for the management of manifestation of psychotic disorders. Haloperidol is specifically indicated as an antipsychotic drug useful for the treatment of acute and chronic schizophrenia.
Presently, haloperidol is available as conventional tablets. These noncontrolled dosage tablets containing 0.5 mg to 2.0 mg of haloperidol are administered to patients of moderate symptomatology twice or thrice daily, and the same tablet containing 3.0 mg to 5.0 mg of haloperidol are administered to patients of severe symptomatology also twice or thrice daily.
The duration of drug delivery of these conventional dosage forms is almost instant, or at best a few hours. This short duration of drug delivery has at least two detrimental effects. The first is the need for frequent administration that leads to a failure of patient compliance with the dosage schedules. Accompanying this failure is not only the lack of administration effectiveness, but also a possible increase in unwanted side effects arising from patients increasing their dosage to compensate for prior omissions. The second detrimental effect is periodic interval administration almost inevitably leads to a peak level of drug surpassing the amount of drug needed at the time of administration, followed by a decline in the level of drug falling below the amount needed to achieve the desired therapeutic effect.
It is self-evident, in the light of the above discussion, a pressing and critical need exists for a delivery dosage form that can deliver haloperidol at a controlled rate and continuously over a prolonged period of time. The need exists for haloperidol as the prior art has not provided a controlled-delivery form for haloperidol, and because its physical and chemical properties do not lend themselves to controlled delivery forms. That is, haloperidol is light-sensitive, nonhygroscopic and practically insoluble in water, which properties are poorly suited for controlled delivery forms.